Certain surgical procedures known as colostomy, ileostomy and urostomy result in an opening in the abdominal wall, called a stoma, which permits waste discharge from the interior of a body cavity. Since the patient has no control over the waste discharge, it is often necessary for the patient to utilize an ostomy device to protect the stoma and collect the waste material as it is discharged.
Over the years, ostomy devices of a variety of different types and constructions have been utilized. Various materials and adhesives have been developed to increase the utility and wearability of same.
The basic device includes a collection receptacle or pouch connected to an adhesive coated faceplate which mounts the pouch to the body. The pouch includes first and second thin film walls which are sealed by heat welding or the like along their periphery. The pouch has an inlet opening designed to be aligned with the stoma. In one piece devices, the pouch is permanently affixed to the adhesive coated faceplate. In two piece devices, the pouch is detachably mounted to the faceplate by coupling rings or the like. In this way, the pouch can be replaced without removal of the faceplate each time.
For the ostomy device to function properly, it is necessary that it make a fluid-tight connection with the peristomal skin to prevent any liquid, solid, semi-solid or gaseous waste from escaping and a weight bearing connection to support the weight of the device. When the muscle beneath the skin surrounding the stoma is smooth and has sufficient rigidity and the stoma protrudes outwardly beyond the skin surface, a planar faceplate will achieve good results. However, when the rigidity of the muscle surrounding the stoma is lacking due to advanced age or abnormal stretching or the peristomal skin is scarred or indented or the stoma does not protrude sufficiently, the planar faceplate is often not adequate.
The advisability of the use of a convex faceplate in such situations has been previously recognized. See, for example, Galindo U.S. Pat. No. 4,219,023, issued Aug. 26, 1980 and entitled Convex Insert And Ostomy Bag Structure, in this regard. We are also aware of an ostomy device which includes a convex pressure ring as disclosed in Nowak U.S. Pat. No. 4,834,731. However, up until now, there has been no effective process for mass producing ostomy devices with convex adhesive faceplates in a manner which prevents localized drying of the adhesive layer. Moreover, there are no products which include a convexly shaped protective shield with a relatively wrinkle-free surface which, when removed, leaves a uniform, uninterrupted adhesive surface which will ensure an excellent seal with the skin.
When a planar annular faceplate is used, it is commonly stamped from a sheet of dough-like material. After it is formed, one side is heat welded to the pouch surrounding the inlet opening. The other surface is coated with a layer of adhesive which may be deposited on the surface itself or which may be on a microporous wafer or label. The exposed surface of the adhesive is then provided with a sheet of planar release paper which protects the adhesive until use.
When the faceplate has a planar surface, the process of placing the adhesive coating thereon and the release paper over the adhesive is relatively straight-forward and results in an adhesive coating which is uniform and smooth. However, the use of a convex faceplate instead of a planar faceplate presents certain complications in the conventional fabrication process due to the fact that the faceplate disk is convex but the release paper is planar. Because the release paper is planar and hence does not readily fit the convex contour of the disk, the adhesive layer may contain air gaps which result in localized drying of the adhesive. Moreover, the release paper may become wrinkled due to its inability to properly conform to the convex surface. When this occurs, the adhesive layer may contain surface ridges instead of being smooth. Hence, it is not possible to mass-produce convex faceplates of acceptable quality.
In order to overcome these difficulties, we have invented a fabrication process which lends itself to mass production and in which a uniform adhesive coating is formed on the convex surface of the faceplate disk. Instead of conventional release paper, a thin plastic protective shield is provided. The shield is fabricated to have a substantially wrinkle-free surface with a contour which is identical to the contour of the convex surface of the disk. All air gaps in the adhesive are eliminated during the fabrication process. Hence, when the shield is removed, the adhesive coating on the convex surface of the faceplate disk is completely smooth and has no dry areas.
It is, therefore, a prime object of the present invention to provide a mass producible ostomy device with a convex adhesive faceplate.
It is an another object of the present to provide an ostomy device with a convex adhesive faceplate in which gaps leading to localized drying of the adhesive have been eliminated.
It is another object of the present invention to provide an ostomy device with a convex faceplate and a convex protective shield.
It is another object of the present invention to provide a method for fabricating an ostomy device with a convex adhesive faceplate disk and a convex protective shield with a wrinkle-free surface.
It is another object of the present invention to provide a method for fabricating an ostomy device with a convex faceplate in which the adhesive layer is uniform, smooth and substantially devoid of gaps.
It is another object of the present invention to provide a method for fabricating an ostomy device with a convex adhesive faceplate which employs vacuum forming techniques to form a convex plastic shield.
It is another object of the invention to provide a method for fabricating an ostomy device with a convex adhesive a faceplate wherein a planar plastic sheet is fabricated into a wrinkle-free convex protective shield.
It is another object of the present invention to provide a method for fabricating an ostomy device with a convex adhesive faceplate wherein the plastic protective shield is vacuum formed to ensure that its contours are substantially identical to the contour of the convex surface of the faceplate.